drugset / Trial / NCT06279195
Phenotyping of Idiopathic Pelvic Pain With Real-time Uterine Imaging and Relugolix-Combination Therapy Treatment
Non-randomizedParallel-groupOpen-labelBasic science
Summary
The mechanisms underlying variable efficacy of Relugolix-Combination Therapy (REL-CT) in mitigating unexplained pelvic pain will be evaluated with uterine imaging techniques and quantitative sensory testing.
Timeline
- Start
- 2024-06-01
- Primary completion
- 2025-11-02
- Completion
- 2025-11-02
Outcome
Outcome not reported
Stopped (Business): “Could not obtain approval for the planned study with available funding”
Publications
- Background Hellman KM, Kuhn CS, Tu FF, Dillane KE, Shlobin NA, Senapati S, Zhou X, Li W, Prasad PV. Cine MRI during spontaneous cramps in women with menstrual pain. Am J Obstet Gynecol. 2018 May;218(5):506.e1-506.e8. doi: 10.1016/j.ajog.2018.01.035. Epub 2018 Feb 2.
- Background Kmiecik MJ, Tu FF, Silton RL, Dillane KE, Roth GE, Harte SE, Hellman KM. Cortical mechanisms of visual hypersensitivity in women at risk for chronic pelvic pain. Pain. 2022 Jun 1;163(6):1035-1048. doi: 10.1097/j.pain.0000000000002469. Epub 2021 Aug 27.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Estradiol | Other / unclassified | 1 mg | Oral |
| Subject | Norethindrone | Unknown | 0.5 mg | Oral |
| Subject | Relugolix | Small molecule | 40 mg | Oral |